OsvaRen Tablets

WHAT OSVARENIS USED FOR

OsvaRen® is used to treat high blood phosphate levels in patients with chronic kidney impairment who are on dialysis (haemodialysis, peritoneal dialysis).

OsvaRen® belongs to a group of medicines known as phosphate binders. Phosphate is a mineral that affects the health of bones. When your kidney function is impaired you tend to have high phosphate levels in the blood. This can put you at risk of bone problems.

OsvaRen® binds phosphate and thereby balances your phosphate levels.

Do not take OsvaRen

if you are hypersensitive (allergic) to calcium acetate, magnesium carbonate or any of the other ingredients of OsvaRen®

if your phosphate blood levels are too low • if you have raised calcium blood values.

This can arise due to vitamin-D overdose, tumours of the lung, breast, kidneys or blood, bone metastases, certain lung disorders (sarcoidosis) or from bone loss as a consequence of lack of exercise.

if you have raised magnesium values in the blood and/or corresponding signs

if you have the heart rhythm disturbance called 3rd degree AV-block.

if you suffer from muscular fatigue, including that of the eye muscles and weakness of the muscles used in swallowing, chewing and breathing (myasthenia gravis).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The calcium value in the blood is to be monitored if the following are being taken:

vitamin D, as it increases the level of calcium in your body

certain diuretic substances (water pills), such as hydrochlorothiazide, as the calcium

digoxin (a cardiac glycoside), a medicine to enhance the performance of the heart - nitrofurantoin, a substance to treat urinary tract infections

penicillamine, a medicine to treat chronic inflammation of the joints

OsvaRen can increase the levels and hence the effect of the following medicines:

levothyroxine, a drug used in impaired function of the thyroid gland

OsvaRen can increase the calcium values and hence the effect of the following agents:

digitalis glycosides (cardiac glycosides such as digoxin) as a medicine to enhance the performance of the heart

adrenaline, a substance to control allergic reactions and to treat shock Possible consequences can even lead to severe disorders of heart rhythm.

If you need a medicine like digitalis glycosides (such as digoxin or digitoxin) your doctor will do ECG monitoring.

OsvaRen can reduce the effect of the following medicine:

Calcium antagonists, such as verapamil, an agent to lower blood pressure.

No other oral medicines mentioned in this leaflet should be taken within the period 2 hours before and 3 hours after the intake of OsvaRen.

Taking OsvaRen with food and drink

OsvaRen® should be taken with meals.

Pregnancy and breast-feeding

There are no data available on the use of OsvaRen during pregnancy and breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You should take OsvaRen® only if your treating physician believes that the potential benefits outweigh the risk. Your calcium and magnesium levels will be checked regularly.

Breastfeeding

Breastfeeding is not recommended if you take OsvaRen®.

Driving and using machines

No particular precautions are necessary.

HOW TO TAKE OSVAREN

Always take OsvaRen® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Use in children and adolescents:

Insufficient information on the use of OsvaRen® is available in these patient groups. Therefore, the administration of OsvaRen® is not recommended in children and adolescents below 18 years of age.

Adults

The dosage to be taken should be prescribed and monitored by your doctor according to the level of phosphate values in your blood.

Recommended dose: 3 to 10 film-coated tablets

Maximum daily dose: 12 film-coated tablets

The recommended starting dose is 3 tablets daily. Take the tablets together with food. The dose is then increased gradually until the desired phosphate levels in the blood are reached, unless you develop high blood calcium levels.

The film-coated tablets are to be taken at mealtimes. Do not crush or chew the tablets. If you cannot swallow the tablets whole, you may break them along the score line immediately before you take them.

Breaking the tablets immediately before taking will avoid the development of an unpleasant taste.

No other oral medicines mentioned in this leaflet should be taken within the period 2 hours before and 3 hours after the intake of OsvaRen®.

OsvaRen® can be used over a longer period, whereby your doctor should decide the exact length of time.

Please speak to you doctor or pharmacist if you have the impression that the effect of OsvaRen® is too strong or too weak.

Side effects

Common

gastro-intestinal disorders such as:

soft stools

nausea

loss of appetite

feeling of fullness - belching

constipation

diarrhoea

increase in calcium blood level, which can occur without symptoms or in connection with symptoms such as

constipation

loss of appetite, - feeling sick

being sick

increase in magnesium blood level, mostly without symptoms

uncommon

moderate to severely increased calcium blood levels, which can be associated with the fol- lowing complaints:

disturbed consciousness such as disorientation, unconsciousness (stupor) and even coma

weakness

confusion

increased excretion of calcium in the urine

hypo-acidification of the blood

heart rhythm disturbances

high blood pressure

hardening of tissues (deposit of calcium salts)

moderate to severely increased magnesium blood levels, which can be associated with the following complaints:

tiredness

muscle weakness

sleepiness ranging to diminished consciousness - lowered pulse

drop in blood pressure

very rare

raised potassium blood levels

HOW TO STORE OSVAREN

Keep out of the reach and sight of children.

Do not use OsvaRen® after the expiry date which is stated on the container after ’EXP’. The expiry date refers to the last day of that month.

After first opening of the container, use OsvaRen® within 3 months.

Keep the container tightly closed in order to protect the contents from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.